- Brincidofovir IV Single and Multiple Dose Data Expected to Report Out in 2017 -
- Comparative Adenovirus Trial with Oral Brincidofovir Expected to Start in 2017 -
- CMX521 for Norovirus Advancing Toward the Clinic -
- Conference Call at
"We are optimistic about 2017 and believe our novel intravenous formulation of brincidofovir may prove to be the optimal way to prevent or treat DNA viral infections, by achieving effective drug levels in the
plasma and infected organs while avoiding gastrointestinal side-effects," said
Recent Highlights and Program Updates:
Development of Intravenous Brincidofovir Formulation Continues
Chimerix remains on track to provide pharmacokinetic, safety and tolerability data from a single dose escalation study of intravenous (IV) brincidofovir in early 2017, with multiple dose studies in patients with active viral infection to follow. In preclinical testing, animals given four weeks of IV brincidofovir showed no signs of gastrointestinal injury, even at plasma exposures several fold higher than those ever achieved with oral dosing. If these early clinical studies of IV-administered brincidofovir continue to demonstrate low or no gastrointestinal side-effects, IV brincidofovir could be in late-stage registrational studies in 2018. Once brincidofovir enters the target cells and is converted to the active antiviral, the drug remains at effective concentrations for several days, potentially allowing for once-weekly dosing. The potential to provide higher drug exposures may allow a much-needed treatment for cytomegalovirus (CMV), adenoviruses (AdV), BK virus, and other DNA viral infections, potentially even in difficult to reach anatomical regions such as the brain.
Detailed 24-Week Data from AdVise Study Presented at IDWeekTM
Building upon the Company's 24-week top-line data announced in
Additional evidence regarding the need for a broad spectrum antiviral was presented at IDWeek by Dr.
Continuing Demand for Brincidofovir through our Expanded Access Programs
The Company continues to receive requests for brincidofovir via our expanded access programs. Through the first ten months of 2016, the Company has granted 263 requests for AdV alone, highlighting the unmet need in this area.
The development of brincidofovir for smallpox continues in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). Following completion of the second animal efficacy study, the Company plans to meet with the FDA to discuss any additional required data for a regulatory decision. Earlier in 2016, Chimerix provided regulators with a summary of the clinical safety and tolerability of the intended three week course of oral brincidofovir in healthy adults and immunocompromised adults and children. In addition, the final study report for the rabbitpox efficacy study of brincidofovir has been submitted to the
Clinical Candidate CMX521 for Norovirus
In addition to the approximately 20 million acute cases of norovirus that occur each year in the
Third Quarter 2016 Financial Results
Net loss narrowed to
Revenues for the third quarter of 2016 decreased to
Research and development expenses decreased to $12.2 million for the third quarter of 2016, compared to $26.5 million for the same period in 2015. This decrease was primarily due to a decrease in the Company's clinical trial expenses associated with the completion of the Phase 3 SUPPRESS and AdVise trials and close-out of the kidney trials, partially offset by an increase in costs related to the development of the IV formulation of brincidofovir and the conduct of the Expanded Access Programs.
General and administrative expenses decreased to $5.8 million for the third quarter of 2016, compared to $8.5 million for the same period in 2015. The decrease was primarily due to a decrease in commercialization expense.
Loss from operations was $17.4 million for the third quarter of 2016, compared to a loss from operations of $32.7 million for the same period in 2015. The narrowed loss was primarily due to decreased research and development expenses, and general and administrative expenses, as previously discussed.
Today's Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to discuss its third quarter 2016 financial results and provide a business update today at 8:30 a.m. ET. To access the live conference call, please dial 877-354-4056 (domestic) or 678-809-1043 (international) at least five minutes prior to the start time and refer to conference ID 97022450.
A live audio webcast of the call will also be available on the Investors section of
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel antivirals in areas of high unmet medical need. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals; and earlier-stage clinical candidates.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company's filings with the Securities and Exchange Commission, including without limitation the Company's most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|Cash and cash equivalents||$||49,358||$||20,605|
|Short-term investments, available-for-sale||200,315||199,729|
|Prepaid expenses and other current assets||4,318||6,071|
|Total current assets||254,370||228,837|
|Property and equipment, net of accumulated depreciation||3,048||3,045|
|Other long-term assets||34||70|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||9,618||20,179|
|Preferred stock, ||—||—|
|Common stock, ||46||46|
|Additional paid-in capital||688,518||675,591|
|Accumulated other comprehensive loss, net||(366||)||(764||)|
|Total stockholders' equity||287,350||335,459|
|Total liabilities and stockholders' equity||$||297,253||$||355,992|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|Three Months Ended||Nine Months Ended|
|Collaboration and licensing revenue||—||—||—||1,548|
|Research and development||12,247||26,495||46,924||65,611|
|General and administrative||5,827||8,524||19,359||22,068|
|Total operating expenses||18,074||35,019||66,301||87,679|
|Loss from operations||(17,421||)||(32,748||)||(62,579||)||(80,027||)|
|Interest income, net||396||299||1,146||498|
|Other comprehensive loss:|
|Unrealized (loss) gain on investments, net||(98||)||(1,448||)||398||321|
|Per share information:|
|Net loss, basic and diluted||$||(0.37||)||$||(0.70||)||$||(1.33||)||$||(1.84||)|
|Weighted-average shares outstanding, basic and diluted||46,236,749||46,059,112||46,199,110||43,112,314|
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